IP Library › Granted Patent US 12,186,426
Granted Patent B2
US 12,186,426 · App. 16/990,739 · Granted Jan 7, 2025

Solid dosage form

Inventors: Chin Beng Stephen Lim (Willeton, AU); Vivian Bruce Sunderland (Claremont, AU); Yip Hang Eddy Lee (Singapore, SG)
Assignee: IX Biopharma Ltd.
A61K9/0056A61K9/2018A61K9/2095A61K31/00A61K31/135A61K31/137A61K31/439A61K31/4468A61K31/519A61K31/5517
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Quick Facts
Patent No.
US 12,186,426
App. No.
16/990,739
Granted
Jan 7, 2025
Kind
B2
Abstract

There is provided a solid dosage form adapted for the release of a biologically active material in the oral cavity wherein the dosage form includes at least one biologically active material, and at least one matrix forming agent, wherein the dosage form substantially dissolves in the oral cavity. A method of producing the same and a kit including the same are also provided.

Claims (18)

1. A fast disintegrating and dissolving solid freeze-dried wafer dosage form with a porous matrix for the release of a biologically active material in an oral cavity wherein said dosage form comprises:

a) biologically active material at a concentration of 0.02 to 95% by dry weight of the dosage form;

b) a matrix forming agent comprising amylopectin that is not in the form of starch or modified starch at a concentration from 2% to 17% by dry weight of the dosage form; and

c) a further matrix forming agent comprising a carbohydrate chosen from the list consisting of: mannitol, dextrose, lactose, galactose, trehalose and cyclodextrin at a concentration from 5% to 80% by dry weight of the dosage form

wherein said dosage form disintegrates in the oral cavity, and

wherein said biologically active material is absorbed by diffusion directly into the systemic circulation, and

wherein the biologically active material is selected from the group consisting of: anti-arrhythmic agents; anti-hypertensive agents; anti-migraine agents; anxiolytic, sedative, hypnotic and neuroleptic agents; gastro-intestinal agents; histamine H-receptor antagonists; nutritional agents; opioid analgesics; proteins, peptides and recombinant drugs; vasodilators; analgesics and anti-inflammatory agents, and

when analysed by powder x-ray diffraction (XRD), the wafer exhibits peaks located at 2-theta values of approximately 9.58 degrees, approximately 19.68 degrees, and approximately 20.05 degrees.

2. The fast disintegrating and dissolving solid dosage form according to claim 1 , further comprising microcrystalline cellulose.

3. The fast disintegrating and dissolving solid dosage form according to claim 2 , wherein the microcrystalline cellulose is present in an amount from 1 to 10 weight % by dry weight of the dosage form.

4. The fast disintegrating and dissolving solid dosage form according to claim 1 , further comprising glycine.

5. The fast disintegrating and dissolving solid dosage form according to claim 4 , wherein glycine is present in an amount from 0.5 to 5 weight % by dry weight of the dosage form.

6. The fast disintegrating and dissolving solid dosage form according to claim 1 wherein the biologically active material is selected from group consisting of: flecainide, sumatriptan succinate, midazolam, lorazepam, diazepam, temazepam, famotidine, ondansetron, omeprazole, loratadine, Vitamin D, fentanyl, interferon, tadalafil, vardenafil, diclofenac, fexofenadine, and benzocaine.

7. The fast disintegrating and dissolving solid dosage form according to claim 6 wherein the interferon is selected from the group consisting of: alpha- 2 interferon, beta interferon, and gamma interferon.

8. The fast disintegrating and dissolving dosage form of claim 1 comprising: an opioid analgesic, nutritional agent, or protein, peptide and recombinant drug present in an amount from 0.02 to 1 weight % by dry weight of the dosage form.

9. The fast disintegrating and dissolving dosage form of claim 1 comprising: an anxiolytic, a sedative, a hypnotic and neuroleptic agent, a histamine H-receptor antagonist, an anti-hypertensive agent, a vasodilator, analgesic or an anti-inflammatory agent present in an amount from 0.2 to 20 weight % by dry weight of the composition of the dosage form.

10. The fast disintegrating and dissolving dosage form of claim 1 comprising: an anti-arrhythmic agent, an anti-migraine agent, an anxiolytic, a sedative, a hypnotic and neuroleptic agent, a gastro-intestinal agent, a vasodilator, an anti-hypertensive agent, an analgesic or an anti-inflammatory agent present in an amount from 5 to 50 weight % by dry weight of the dosage form.

11. The fast disintegrating and dissolving dosage form of claim 1 comprising: an anti-arrhythmic agent; an anti-hypertensive agent; an anti-migraine agent; an anxiolytic, a sedative, a hypnotic and neuroleptic agent; a gastro-intestinal agent, a histamine H-receptor antagonists, nutritional agent; an opioid analgesic; a protein, a peptide, and recombinant drug; a vasodilator; an analgesic or an anti-inflammatory agent present in an amount from 0.02 to 50 weight % by dry weight of the composition of the dosage form.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 13, 2020
From: LIM, CHIN BENG STEPHEN; SUNDERLAND, VIVIAN BRUCE; LEE, YIP HANG EDDY
To: IX BIOPHARMA PTE LTD.
Reel/Frame 053493/0169 →
CHANGE OF NAME Recorded Aug 13, 2020
From: IX BIOPHARMA PTE LTD.
To: IX BIOPHARMA LTD.
Reel/Frame 053493/0693 →
Priority Claims (4)
SG 200907221-6 · Oct 30, 2009 · national
AU 2012238330 · Oct 11, 2012 · national
AU 2013200684 · Feb 8, 2013 · national
AU 2013200682 · Aug 8, 2013 · national
Continuity (4)
Division 16020880 · Jun 27, 2018
Continuation 14052331 · Oct 11, 2013
Continuation In Part 13504309
Related Publication 20220347095A1 · Nov 3, 2022
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